SAM #BARDA-27-100227

BARDA seeks a two-day medical device development training course for scientists

HHS’s BARDA is seeking a small-business contractor to deliver practical, instructor-led medical-device development training for scientists. - Government buyer: U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA). The contracting contact named is La Vivian Peasant; no specific office is identified. - Requested service: One two-day, in-person Device Development for Scientists course for up to 30 participants at the Constitution Center in Washington, DC. - Course topics: Device discovery and development; clinical studies; FDA pathways, including 510(k), De Novo, PMA, Breakthrough Devices Program, and STeP; commercialization and intellectual property; coding, coverage, and reimbursement; and post-market considerations. - Contractor responsibilities: Provide qualified instructor(s), preparation, an agenda, practical instruction and interactive exercises or case studies, and reusable electronic course materials. Final materials are due at least two business days before training. The single fixed price must include preparation, instruction, materials, travel, lodging, and related expenses. - Government-provided support: The Government provides the venue and coordinates participants. - OEMs and vendors: No OEMs, commercial vendors, or training contractors are named in the opportunity.

Description

The objective of this requirement is to obtain a qualified Contractor to provide a two-day, in-person, instructor-led training course on Device Development for Scientists. The Government’s preferred training dates are November 2–3, 2026, with flexibility for the training to be conducted on mutually agreed-upon dates in January 2027, if necessary

The training shall provide participants with an understanding of the scientific, clinical, regulatory, intellectual property, and commercial considerations involved in medical device development and bringing medical devices to market

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